Optimising Congestive Heart Failure Outpatient Clinic Project (OPTIMAL)

August 21, 2012 updated by: Thomas Kahan, Karolinska Institutet

Optimising Congestive Heart Failure Outpatient Clinic Project (OPTIMAL)

This study examines whether a nurse monitored management program at the hospital heart failure outpatient clinic can improve quality of life in elderly patients with chronic heart failure, as compared to standard treatment in primary healthcare.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients 60 years of age or more hospitalized with heart failure according to New York Heart Association (NYHA) class II-IV and systolic dysfunction (left ventricular ejection fraction less than 0.45) are investigated before discharge and than randomized to the nurse monitored management program or to standard care. Examinations are performed at 0, 6, 12, and 18 months, and include clinical signs and symptoms, quality of life, biochemical assessment, echocardiography and drugs used. The study will be completed when all patients have passed the 18 month follow up examination. Quality of life is assessed by the Nottingham health profile.

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 182 88
        • Danderyd University Hospital Corp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients 60 years of age or older
  • Hospitalized with heart failure according to New York Heart Association (NYHA) class II-IV
  • Left ventricular systolic dysfunction with an ejection fraction below 0.45, by echocardiography

Exclusion Criteria:

  • An acute myocardial infarction or unstable angina pectoris within the last three months
  • Valvular stenosis
  • Dementia
  • Severe concomitant disease
  • Refusal to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nurse monitored heart failure program
To assess whether a nurse monitored management programme at the hospital outpatient clinic would improve quality of life, as compared to standard primary health care.
Procedure: Nurse monitored heart failure program
Standard program for a heart failure clinic with information, education, drug titration
Active Comparator: Standard primary health care
To assess whether a nurse monitored management programme at the hospital outpatient clinic would improve quality of life, as compared to standard primary health care.
Procedure: Standard primary health care
Standard care in primary care according to national guidelines but at the discretion of the primary care caregiver

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 18 months
Nottingham health profile used for quality of life assessment
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalizations
Time Frame: 18 months
Registry data that cover all hospitalizations for all patients
18 months
Evaluation of heart failure medication
Time Frame: 18 months
Whether patients receive appropriate drug therapy (drug classes) and reach target doses of heart failure medication
18 months
Mortality
Time Frame: 18 months
Mortality from death certificates obtained.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Region Stockholm

Investigators

  • Study Chair: Magnus Edner, MD, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1996

Primary Completion (Actual)

June 1, 2001

Study Completion (Actual)

June 1, 2001

Study Registration Dates

First Submitted

August 19, 2012

First Submitted That Met QC Criteria

August 21, 2012

First Posted (Estimate)

August 24, 2012

Study Record Updates

Last Update Posted (Estimate)

August 24, 2012

Last Update Submitted That Met QC Criteria

August 21, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPTIMAL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Nurse monitored heart failure program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe